HHS Announces Crackdown on Health Data Blocking

WASHINGTON--Today, the U.S. Department of Health and Human Services (HHS) announced that Secretary Robert F. Kennedy, Jr. has directed HHS to increase resources dedicated to curbing the harmful practice of information blocking. HHS will take an active enforcement against health care entities that restrict patients’ engagement in their care by blocking the access, exchange, and use of electronic health information.

The 21st Century Cures Act of 2016 authorized the Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC) and HHS Office of Inspector General (OIG) to take enforcement actions to hold those who block patient information accountable and to prevent future violations.  As a result, ASTP/ONC, the principal federal entity charged with coordination of nationwide efforts to implement and use the most advanced health information technology, and the OIG, the primary investigative division of HHS, will play leading roles in this initiative.

Information blocking was not a priority under the Biden Administration. That changed under President Trump and Secretary Kennedy.

“Unblocking the flow of health information is critical to unleashing health IT innovation and transforming our healthcare ecosystem,” said Deputy Secretary of Health and Human Services Jim O’Neill. “We will take appropriate action against any health care actors who are found to be blocking health data for patients, caregivers, providers, health innovators, and others.”

Many patients rely on access to their health information, directly, through their providers or through the use of health apps, to monitor their chronic conditions, to adhere to their treatment plans, to find errors in their health records, and to track their progress in wellness and disease management programs. Empowering individuals to take control of their health is critical to delivering on Secretary Kennedy’s promise to Make America Healthy Again.

“Patients must have unfettered access to their health information as guaranteed by law. Providers and certain health IT entities have a legal duty to ensure that information flows where and when it’s needed,” said Acting Inspector General Juliet T. Hodgkins. “HHS-OIG will deploy all available authorities to investigate and hold violators accountable. We are committed to enforcing the law and protecting patients’ access to health information.”

“We have already begun reviewing reports of information blocking against developers of certified health IT under the ONC Health IT Certification Program and are providing technical assistance to our colleagues at OIG for investigations,” said Tom Keane, MD, Assistant Secretary for Technology Policy and National Coordinator for Health Information Technology.

The Trump Administration’s commitment to unblocking the flow of health information continues efforts that began during President Trump’s first term, under which the ONC Cures Act Final Rule was published. The final rule, which sought to improve health information access and health IT choice, maintains that (1) patients should have easy electronic access to their EHI at no cost, including via apps of their choice; and that (2) health care providers should be able to choose the digital tools that allow them to provide the best care, without excessive costs or technical barriers.

Today’s announcement is a warning to actors still engaging in information blocking to come into compliance with the rules governing the flow of patient information and a call to action for patients, providers, payers, local health departments, and health IT companies to report alleged information blocking.

For Patients and Innovators: If you are a patient who has experienced information blocking in your or your family’s health journey, an innovator trying to improve health care or reduce costs, or have otherwise observed information blocking in a health setting, you should report it through ASTP/ONC’s Report Information Blocking Portal.

For Actors Subject to the Information Blocking Regulations: If it is determined that you committed information blocking, the following consequences exist:

• If you are a health care provider participating in certain Centers for Medicare & Medicaid Services programs, you could be subject to disincentives under those programs.
• If you are a health IT developer of certified health IT, or meet the definition of a health information network or health information exchange, you could face a substantial civil monetary penalty of up to $1M per violation.
• If you are a developer with product(s) certified under the ONC Health IT Certification Program, you could have your certifications terminated and be banned from the Certification Program.

More information can be found at healthit.gov/informationblocking and via ASTP/ONC’s X account, @HHS_TechPolicy.